Nancy Olivieri, a Toronto haematologist, helped evaluate Apotex’s deferiprone for patients with thalassaemia in clinical research beginning in the 1980s and continuing through the 1990s. During the trial, she became concerned that the drug was ineffective for some patients and reported those concerns to the research ethics board and Apotex. The ethics board directed her to inform participants, but Apotex argued that a confidentiality agreement barred disclosure and, in 1996, threatened to pursue legal remedies if she warned patients. Olivieri disclosed her concerns, after which Apotex ended the portion of the study in which she participated.
In 1998, the New England Journal of Medicine published a paper by Olivieri and seven co-authors reporting further evidence that deferiprone could cause progressive hepatic fibrosis. The findings were contested by Apotex using data from its own clinical trials, and the drug was later approved in more than 50 countries, including the United States in 2011 through the FDA’s accelerated-approval program, but not in Canada according to the supplied account. A Canadian Association of University Teachers investigation also found that Gideon Koren anonymously sent disparaging letters about Olivieri; DNA evidence connected him to the letters, and he was reprimanded. Olivieri received the 2009 AAAS Award for Scientific Freedom and Responsibility and the 2023 John Maddox Prize. The account reports no monetary settlement or regulatory penalty against Apotex.
